CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Kuvandrug
Likely dose
Kuvan 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02353312
NCT02353312N/ACompleted
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Rhode Island Diastolic Dysfunction - Heart Failure

Providence VA Medical Center·interventional·Posted Feb 2, 2015·Updated Jul 3, 2025

In Brief

A clinical study evaluating Kuvan for Heart Failure and Cardiovascular Disease. Completed, enrolled 28 participants across 1 site.

Detailed Summary

To study the hypothesis that treating patients with underlying diastolic dysfunction with oral Kuvan® (BH4, also known as tetrahydrobiopterin) in addition to current best practices will improve metabolic and echocardiographic diastolic function parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Cardiovascular Disease
CountriesUnited States
CollaboratorsBioMarin Pharmaceutical, Lifespan

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2, 2015
Enrollment StartMar 1, 2015
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.4 years ago

Interventions

Kuvandrug

Kuvan® (sapropterin dihydrochloride) will be initiated at 10mg/kg/day with meals for one week. After telephone contact on day 7, assuming no adverse effects are noted, the patient will be instructed to increase their daily dose to 20mg/kg/day with meals for the remainder of the 3 months.